Presented by Ms. Geihan (Gigi) Rizkalla
Thursday, July 6, 2017; 1:00pm – 2:30pm EDT (GMT -4)
Sales of medical devices in Canada are estimated to make up the world’s 9th richest market for these commodities, and financial experts continue to release favorable forecasts. Many of these devices are imported…and manufacturers shipping products to Canada must be aware of their legal obligations.
The Canadian government recently enacted sweeping changes to the Food and Drugs Act that required manufacturers of medical devices to adapt to Health Canada’s strengthened enforcement programs and heightened public transparency requirements. In 2019 Health Canada will again implement significant changes and manufactures will need to ensure they are working towards compliance in order to avoid any disruption to their Canadian business.
Regulations for introducing and keeping devices on the Canadian market are not the same as the rules used at the FDA. Some differences are quite subtle, others are very substantial. Now, even manufacturers with long experience in the Canadian market are facing compliance challenges, including the mandatory transition from CMDCAS ISO 13485 to MDSAP.
On July 6, 2017 FOI Services hosted a 90-minute audio-format presentation describing the current Canadian regulatory process for approving medical devices – and, once approved, keeping them on the market in a climate that gives Health Canada broad new powers and a new organization to deliver compliance and enforcement programs. You'll come away with an understanding of the steps to market authorization, the classification system for devices and an overview of the compliance process...including the common misunderstandings and the potential consequences of non-compliance.
What You'll Learn:
- The criteria defining a medical device
- Determining the class of your medical device
- Important steps to take to successfully complete a medical device license application
- The current costs for your device license and annual renewal – and how Health Canada arrives at the prices for your device
- The changes to Quality Management Systems needed to comply with MDSAP requirements
- How non-compliance could lead to fines of up to $5,000,000 per day
- Ongoing compliance requirements
- Investigational testing requirements
- Provincial reimbursement programs
What You'll Get:
- Up-to- date information to help you understand the Canadian device approval process
- The depth of submission required for different device classes
- An understanding of how your company is affected by the new legislation
- A basis for determining if you should introduce your product onto the Canadian market
- Resources for the requirements for maintaining compliance of marketed products
- An experienced and approachable instructor
- Time for questions and answers
Who Will Benefit:
- Regulatory affairs professionals
- Quality assurance/quality control teams
- Product registration personnel
- Project management
- Compliance professionals
- Business development executives
About Your Instructor:
Geihan (Gigi) Rizkalla, B.Sc., M.Sc., ASQ has over 25 years of experience in Canadian and US medical devices regulatory affairs and compliance. Gigi began her career in the medical device industry, where she quickly progressed through quality assurance and fulfilling roles of increasing responsibility at medium and large medical devices companies, rising to Director of QA/QC at a major Canadian diagnostics company.
In addition to her long experience developing and maintaining Quality Management Systems to ensure compliance with ISO 13485 CMDCAS and FDA 21 CFR Part 820, Gigi is highly skilled in successfully preparing and filing Class II, III and IV medical device license submissions with Health Canada. For the past five years she has been an Associate with McCarthy Consultant Services, Inc. (MCSI), specializing in medical device consultation and successfully assisting clients in this arena.
If you have questions about the content and coverage of this presentation, you are invited to contact MCSI directly at firstname.lastname@example.org. For more information about MCSI, a respected Canadian regulatory consulting group dedicated to helping drug and device companies worldwide, visit the company's website at www.mccarthyconsultant.com.
Try the Audio Package for $449. The package includes online delivery of an mp3 file of the entire presentation, including the question and answer session, as well as all of the handouts.